Indian Medical Device Industry Challenges New Sterilisation Labelling Rule
A new rule requires medical device makers to label sterilisation facility licence numbers, raising compliance concerns.
The Indian health ministry has introduced a new amendment to the Medical Devices Rules, 2017, mandating that manufacturers include the licence number of any outsourced sterilisation facility on their product labels. This change, announced on August 14, 2026, will become compulsory six months from the notification date. The announcement has sparked concerns among medical device manufacturers about increased compliance burdens and potential export delays.
Industry Pushback
The Association of Indian Medical Device Industry (AiMeD) has voiced strong opposition to the new requirement. According to the association, manufacturers are already required to obtain 'loan licences' when using external facilities for sterilisation processes like gamma radiation or ethylene oxide (EO). AiMeD argues that the new rule adds another layer of complexity to the compliance process, potentially hindering the industry's efficiency and competitiveness.
AiMeD has indicated that the new regulation could disrupt export shipments. If a sterilisation facility listed on a product label accumulates a backlog or becomes unavailable, manufacturers may not be able to switch to another facility without causing delays. The association estimates that this could extend shipment delays from the current one week to up to three weeks.
Calls for Clarity and Exemptions
One of the major concerns for AiMeD is the lack of clarity regarding international manufacturers. The association has requested guidance on whether foreign manufacturers and their sterilisation facilities will require Indian licences and if the rule will apply to their packaging. Additionally, AiMeD seeks clarification on how to manage existing packaging stock before the rule takes effect.
While the government has provided a six-month transition period for manufacturers to comply, AiMeD is urging a reconsideration of the rule. The association argues that patient safety and product traceability can be ensured without imposing additional burdens on manufacturers, which could negatively impact their global competitiveness.
Government's Stance
The health ministry's notification followed a period of consultation with the Drugs Technical Advisory Board and consideration of public objections and suggestions on the draft rules. Despite industry pushback, the government maintains that the new labelling requirement is essential for ensuring transparency and accountability in the sterilisation process.
As the implementation deadline approaches, the medical device industry continues to seek dialogue with the government to address their concerns. The outcome of these discussions could significantly influence the operational strategies of manufacturers both domestically and internationally.